NCT00743938已完成2 期
A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients
Bristol-Myers Squibb10 个研究点 分布在 2 个国家目标入组 141 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 10
- 主要终点
- To compare the progression-free survival of patients on BMS-690514 with those on erlotinib
研究概览
简要总结
The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG PS of 0 or 1
- •Histologically confirmed NSCLC
- •Adequate amount of tumor (archived or fresh) for biomarker evaluation
- •Received one to two regimens of chemotherapy (with at least one platinum-containing)
- •Serum creatinine of less than 1.0 mg/dL or a 24 hour creatinine clearance of greater than 60 mL/min
- •Stable control of blood pressure on agents other than calcium channel blockers
- •Women of child-bearing potential must avoid pregnancy or maintain adequate contraception
- •Must be able to swallow pills and take the medications at the same time every day on an empty stomach
排除标准
- •ECOG PS 2 or greater
- •Women unwilling to avoid pregnancy or use adequate contraception
- •Symptomatic brain metastases
- •Recent history of TIA, CVA, or thrombotic/thromboembolic event (within 6 months)
- •History of hemoptysis greater than 10 mL/day
- •Significant cardiovascular disease
- •Uncontrolled diarrhea, Crohn's disease, ulcerative colitis, or any malabsorptive disease
- •History of use of other TKIs
- •Uncontrolled hypertension
研究组 & 干预措施
A1
Experimental
干预措施: BMS-690514 (Drug)
B2
Active Comparator
干预措施: Erlotinib (Drug)
结局指标
主要结局
To compare the progression-free survival of patients on BMS-690514 with those on erlotinib
时间窗: CT/MRI at baseline and every 6 weeks for 36 weeks
次要结局
- To compare the overall survival between BMS-690514 and erlotinib(15 months)
- To estimate the overall response rate of BMS-690514 or erlotinib(15 months)
- To estimate the tumor size change and PFS rate at 6 weeks(6 weeks)
- To assess safety and tolerability of BMS-690514 and erlotinib(15 months)
- To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib(15 months)
- To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients(Days 1,8,15, 29)
研究者
研究点 (10)
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